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U.S. FDA Medical Device Powered Toothbrush Requirements

FDA Medical Device Definition: A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

Registrar Corp assists Powered Toothbrush companies with:

  • FDA Powered Toothbrush Establishment Registration
  • FDA Powered Toothbrush Listing
  • FDA Powered Toothbrush Label Requirements and Exceptions
  • FDA Powered Toothbrush Import Information
  • FDA Powered Toothbrush Detentions (Powered Toothbrush Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Powered Toothbrush Manufacturers (Powered Toothbrush Suppliers)
       - Powered Toothbrush Distributors
       - Powered Toothbrush Processors
       - Powered Toothbrush Repackers
       - Powered Toothbrush Relabelers
       - Powered Toothbrush Exporters
       - Powered Toothbrush Importers
For more information about Powered Toothbrush Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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